Primary outcomeMean· Baseline and 6 months
Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)
| Group | Value (μU/ml) | Spread |
|---|---|---|
| Exenatide | 214 | 60 |
| Sitagliptin | 149 | 20 |
| Glimepiride | 133 | 19 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
NCTNCT00775684 (opens ClinicalTrials.gov in a new tab)Other id808425
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 47 participants (actual)
- Sponsor
- University of Pennsylvania · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Oct 2008
- Primary completion
- Nov 2012
- Completion
- Nov 2012
- First posted
- 20 Oct 2008 (estimated)
- Last update posted
- 7 Jun 2022
- Conditions
- Pre-diabetes · Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010201120122013
- N/A
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
NCT00775684Oct 2008 to Nov 2012
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this study is to determine if exenatide and sitagliptin increase the amount of insulin made by the pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.
Interventions
- ExenatideDrug
- SitagliptinDrug
- GlimepirideDrug
Arms3
Experimental
Exenatide
Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects
Experimental
Sitagliptin
Sitagliptin (Januvia®)-100 mg by mouth every morning
Active comparator
Glimepiride
Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose \< 110mg/dl
Primary outcomes2
Outcomes the sponsor listed as primary.
Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)
Time frame · Baseline and 6 months
Registry description
The acute insulin response to arginine (AIRarg) performed during the 340mg/dl glucose clamp allows for estimation of the the beta-cell secretory capacity (AIRmax) or functional beta-cell mass. Changes from baseline to 6 months of AIRmax were compared across groups
Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)
Time frame · Baseline and 6 months
Registry description
AGRmin is performed during the 340mg/dl glucose clamp allows for estimation of the minimum alpha-cell glucagon secretion. Changes from baseline to 6 months of AGRmin were compared across groups.
Secondary outcomes(3)
Change in Acute Insulin Response to Arginine. (AIRarg)
Time frame · Baseline and 6 months
Registry description
The changes in B-cell insulin secretion, Acute Insulin Response to arginine (AIRarg) after 6 months were compared to baseline AIRarg for each group. Listed below are AIRarg at baseline and 6 months for each group.
Insulin Sensitivity at Baseline and 6 Months
Time frame · Baseline and 6 months
Registry description
Insulin sensitivity (M/I) was determined by dividing the mean glucose infusion rate required during the 230 mg/dL glucose clamp (M) by the mean prestimulus insulin level (I) between 40 and 45 min of the glucose infusion The mean difference after 6 months in insulin sensitivity (M/I) were compared
PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months
Time frame · Baseline and 6 months
Registry description
Between ∼60 and 250 mg/dL, the magnitude of AIRarg is a linear function of the plasma glucose level, so the difference in AIRarg at fasting and 230 mg/dL glucose levels divided by the difference in plasma glucose (ΔAIRarg/ΔPG) gives the glucose-potentiation slope (GPS) (8,24-26). Using the y-intercept (b) from the line created by these two points, the plasma glucose level at which half-maximal insulin secretion is achieved (PG50) is derived from solving the equation 1/2 (AIRmax) = (GPS · PG50) + b, and provides a measure of β-cell sensitivity to glucose The mean difference after 6 months in PG 50 were compared. Listed below are the PG50 values at baseline and 6 months.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline and 6 months
Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Exenatide | 51 | 12 |
| Sitagliptin | 55 | 8 |
| Glimepiride | 37 | 6 |
Secondary and other outcome results(3)
Secondary outcomeMean· Baseline and 6 months
Change in Acute Insulin Response to Arginine. (AIRarg)
| Group | Value (uU/mL) | Spread |
|---|---|---|
| AIRarg Exenatide | 52 | 14 |
| AIRarg Sitagliptin | 35 | 4 |
| AIRarg Glimepiride | 44 | 6 |
Secondary outcomeMean· Baseline and 6 months
Insulin Sensitivity at Baseline and 6 Months
| Group | Value (((mg/kg) /min) /uU/mL) | Spread |
|---|---|---|
| M/I Exenatide | 0.3 | 0.1 |
| M/I Sitagliptin | 0.3 | 0.0 |
| M/I Glimepiride | 0.3 | 0.1 |
Secondary outcomeMean· Baseline and 6 months
PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months
| Group | Value (mg/dL) | Spread |
|---|---|---|
| P50 Exenatide | 175 | 13 |
| P50 Sitagliptin | 226 | 12 |
| P50 Glimepiride | 168 | 17 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatideExenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects Exenatide: Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects | 0 / 17 | 0 / 17 | 0 / 17 |
| SitagliptinSitagliptin (Januvia®)-100 mg by mouth every morning Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning | 0 / 13 | 0 / 13 | 0 / 13 |
| GlimepirideGlimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose \< 110mg/dl Glimepiride: Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose \< 110mg/dl | 0 / 17 | 0 / 17 | 0 / 17 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Male and female patients age 18 to 70 years.
2. Ability to provide written informed consent
3. Mentally stable and able to comply with the procedures of the study protocol
4. Clinical history compatible with impaired fasting glucose or early T2D as defined by a plasma glucose concentration between 110-159 mg/dl following a 12 hour overnight fast performed off any anti-diabetogenic agent for at least 2 weeks (6 weeks for thiazolidinediones)
5. Stable body weight (+ 5%) for at least 2 weeks
6. Female Patients: Agree to use adequate contraception if reproductively capable. Adequate contraception includes either a hormonal or barrier method, or surgical sterilization.
Exclusion Criteria:
1. Diagnosis of type 1 diabetes
2. Receiving insulin, exenatide (Byetta®), or sitagliptin (Januvia®) treatment or taking \> 2 oral anti-diabetogenic agents for the treatment of diabetes
3. BMI \> 44 kg/m2
4. Allergy to any sulfa-containing compounds
5. Uncontrolled hypertension (Systolic Blood Pressure \>160 or Diastolic Blood Pressure \> 100 mmHg)
6. Uncontrolled hyperlipidemia (triglycerides \> 500 or LDL \> 160 mg/dl)
7. Elevation of liver function tests \> 2 times the upper limit of normal
8. Estimated Glomerular Filtration Rate (GFR) \< 55 ml/min/1.73m2 (46)
9. Hyperkalemia (serum potassium \> 5.5 mmol/L)
10. Moderate anemia (hemoglobin concentration \< 12 g/dl in men and \< 11 g/dl in women)
11. Female patients: pregnant or lactating
12. Hepatic cirrhosis
13. Known active alcohol or substance abuse
14. Active cardiovascular disease
15. Use of any investigational agent within 6 weeks of the baseline visit
16. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
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